Impact of trainees involvement on surgical outcomes of abdominal and laparoscopic myomectomy.

BACKGROUND: To determine the association of trainees involvement with surgical outcomes of abdominal and laparoscopic myomectomy including operative time, rate of transfusion, and complications. METHODS: A retrospective cohort study of 1145 patients who underwent an abdominal or laparoscopic myomectomy from 2008-2012 using the American College of Surgeons National Surgical Quality Improvement Program database (Canadian Task Force Classification II-2). RESULTS: Overall, 64% of myomectomies involved trainees. Trainees involvement was associated with a longer operative time for abdominal myomectomies (mean difference 20.17 minutes, 95% Confidence Interval (CI) [11.37,28.97], p < 0.01) overall and when stratified by fibroid burden. For laparoscopic myomectomy, there was no difference in operative time between trainees vs no trainees involvement (mean difference 4.64 minutes, 95% CI [-18.07,27.35], p = 0.67). There was a higher rate of transfusion with trainees involvement for abdominal myomectomies (10% vs 2%, p < 0.01; Odds Ratio (OR) 5.62, 95% CI [2.53,12.51], p < 0.01). Trainees involvement was not found to be associated with rate of transfusion for laparoscopic myomectomy (4% vs 5%, p = 0.86; OR 0.82, 95% CI [0.16,4.14], p = 0.81). For abdominal myomectomy, there was a higher rate of overall complications (15% vs 5%, p < 0.01; OR 2.96, 95% CI [1.77,4.93], p < 0.01) and minor complications (14% vs 4%, p < 0.01; OR 3.71, 95% CI [2.09,6.57], p < 0.01) with no difference in major complications (3% vs 2%, p = 0.23). For laparoscopic myomectomy, there was no difference in overall (6% vs 10% p = 0.41; OR 0.59, 95% CI [0.18,2.01], p = 0.40), major (2% vs 0%, p = 0.38), or minor (5% vs 10%, p = 0.32; OR 0.52, 95% CI [0.15,1.79], p = 0.30) complications. CONCLUSION: Trainees involvement was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy, however, did not impact surgical outcomes for laparoscopic myomectomy.

TITLE: Trainees Involvement in MyomectomyThe goal of our study was to determine the association of trainees involvement with surgical outcomes of fibroid excision surgery or myomectomy. We conducted a study of abdominal and laparoscopic myomectomies using an international surgical database. We found that trainees involvement in myomectomy was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy. However, trainees involvement did not impact surgical outcomes for laparoscopic myomectomy.

Laparoscopic Trocars: Marketed Versus True Dimensions-A Descriptive Study.

STUDY OBJECTIVE: To establish true dimensions of single-use laparoscopic trocars compared with marketed dimensions, calculate corresponding incision sizes, examine what trocar size categories are based on, and outline accessibility of information regarding true dimensions. DESIGN: Descriptive study. SETTING: Laparoscopic disposable trocars available in North America and Europe are marketed in several distinct categories. In practice, trocars in the same-size category exhibit different functionality (ability to introduce instruments/needles and retrieve specimens) and warrant different incision lengths. PATIENTS: Not applicable. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: True dimensions for 125 trocars (bladeless, optical, and balloon) were obtained from 9 vendors covering 8 marketed size categories (3-, 3.5-, 5-, 8-, 10-, 11-, 12-, and 15-mm trocars). On average, true inner cannula diameter was 0.92 mm wider (SD, 0.41 mm; range, 0-2.4 mm) than the marketed size category, with the widest range in the 5 mm category. For 5-mm trocars, mean true inner diameter was 6.1 mm (SD, 0.45; range, 5.5-7.4) and true outer diameter 8.3 mm (SD, 0.71; range, 8.0-10.7). For 12-mm trocars, mean true inner diameter was 13.0 mm (SD, 0.21; range, 12-13.3) and outer diameter 15.3 mm (SD, 0.48; range, 14.4-16.8). Five-mm trocars necessitate a mean incision size of 13.0 mm (SD, 1.1; range, 12.1-16.8) and 12-mm trocars a mean incision of 24.0 mm (SD, 0.75; range, 22.6-26.4). No vendors stated actual diameters on company website or catalog. In one instance the Instructions For Use document contained the true inner diameter. CONCLUSION: Trocar size categories give a false sense of standardization when in actuality there are considerable within-category differences in both inner and outer diameters, corresponding to differences in functionality and required incision sizes. There is no universally applied definition for trocar size categories. Accessibility of information on true dimensions is limited.

Preoperative Hematocrit Level and Associated Risk of Transfusion for Myomectomy Based on Myoma Burden and Surgical Route.

STUDY OBJECTIVE: To determine the association between preoperative hematocrit level and risk of blood transfusion for laparotomic and laparoscopic myomectomy based on myoma burden and surgical route. DESIGN: A cohort study of prospectively collected data. SETTING: American College of Surgeons National Surgical Quality Improvement Program participating institutions. PATIENTS: A total of 26 229 women who underwent a laparotomic or laparoscopic myomectomy from 2010 to 2020. INTERVENTIONS: The primary outcome assessed was the risk of transfusion based on preoperative hematocrit level. This was evaluated with respect to myoma burden and surgical route. MEASUREMENTS AND MAIN RESULTS: There were 26 229 women who underwent a myomectomy during the study interval, 2345 women (9%) of whom required a blood transfusion. Compared with patients who did not require transfusion, those who did had lower median preoperative hematocrit levels (34.7 vs 38.2). Patients were stratified by surgical approach (laparotomic vs laparoscopic) and myoma burden (1-4 myomas/weight ≤250 g or ≥5 myomas/weight >250 g) using Current Procedural Terminology codes (58140, 58146, 58545, 58546). In all categories, there was an inverse relationship between blood transfusion and preoperative hematocrit level with increasing risk depending on preoperative hematocrit range. The odds ratios comparing hematocrit level of 29% with 39% were 6.16 (95% confidence interval [CI], 5.15-7.36), 4.92 (95% CI, 4.19-5.78), 4.85 (95% CI, 3.72-6.33), and 5.2 (95% CI, 3.63-7.43) for patients with laparotomic (1-4 myomas/≤250 g, ≥5 myomas/>250 g) and laparoscopic myomectomy (1-4 myomas/≤250 g, 5 myomas/>250 g), respectively. CONCLUSION: Incremental increases in hematocrit result in a significantly decreased risk of blood transfusion at the time of myomectomy.

Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.

Study Objective: To examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene® Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing. Methods: The prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound ≤10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of ≥150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month 24 and Month 36. Data collected included gynecological adverse events, description of last menstrual period, contraception status, self-report of pregnancy, medical or surgical interventions to treat abnormal uterine bleeding, satisfaction, recommendation, and quality of life (QoL). QoL outcomes were measured with the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™). Results: 201 subjects completed their Month 36 final study visit. Subject outcomes were comparable to those at Month 12. Eighty-nine percent of subjects reported amenorrhea, a lighter-than-normal, or normal period, 91% of subjects had no or slight limitations in MIQ measured activities, and 85% reported premenstrual symptoms at a low frequency. Eighty-five percent of the subjects were satisfied or very satisfied. The cumulative incidence of hysterectomy was 5% and reintervention was 8.7%. Forty-nine gynecologic adverse events (AE) were reported; one non-serious AE, postcoital bleeding, was reported as related to the procedure. No serious device-related or procedure-related AEs were reported. Conclusion: Study data demonstrate that the positive effects of Cerene Cryotherapy Device treatment are sustained through Month 36 and that the risks associated with the device and procedure are low (ClinicalTrials.gov; NCT02842736).

A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding owing to benign causes. DESIGN: A prospective, multi-center, single-arm, open label, non-randomized study. SETTING: At 11 academic and private practices in North America: 8 clinic sites in the United States, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). PATIENTS: A total of 242 subjects comprise the intent-to-treat population. Subject demographics were similar to other published endometrial ablation studies performed. INTERVENTIONS: Subjects were treated with a single-use disposable cryoablation device (Cerene) which delivers a 2.5-minute treatment to the endometrium. Analgesia and local anesthesia were administered per investigator discretion; intravenous sedation was used in only 3% of subjects and no general anesthesia was used. MEASUREMENTS AND MAIN RESULTS: There were no device or procedure-related serious adverse events, nor unanticipated adverse device effects. Cerene cryoablation was effective in reducing menstrual blood loss, which was measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 at pretreatment (±332.1) to 51 at 12 months posttreatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at month 12. CONCLUSION: This study demonstrated that Cerene cryoablation is safe and effective, offering the benefits of reduced menstrual blood loss with limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

Essentials in Minimally Invasive Gynecology Manual Skills Construct Validation Trial.

OBJECTIVE: To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems. METHODS: A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]-certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician-gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates. RESULTS: Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P<.05): L-1, 256 (±59) vs 187 (±45); L-2, 274 (±38) vs 232 (±55); L-3, 344 (±101) vs 284 (±107); L-4, 481 (±126) vs 376 (±141); L-5, 494 (±106) vs 420 (±100); H-1, 176 (±56) vs 141 (±48); and H-2, 200 (±96) vs 150 (±37). Incompletion rates were highest in the novice cohort and lowest in the expert group. Exercise errors were significantly less and accuracy was greater in the expert group compared with all other groups. CONCLUSION: Validity evidence was established for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems by distinguishing PGY-1 from PGY-3 trainees and proficient from expert gynecologic surgeons.